Early Access & Market Access

SOLUTIONS

EARLY ACCESS

Intsel Chimos specializes in facilitating early access, providing comprehensive support to pharmaceutical companies introducing therapies into the French healthcare system — before and also after Marketing Authorization.

Compassionate Use - Autorisation Accès Compassionnel (AAC)

For patients suffering from serious or life-threatening diseases with no therapeutic alternatives, compassionate use offers a vital channel to access promising treatments still under development. These programs are granted on a case-by-case patient basis outside of clinical trials.

Our Role in Compassionate Use:

Regulatory Expertise: We assist sponsors in navigating the regulatory framework for AAC submissions in France.
Compassionate Use Access: We ensure that compassionate use requests are submitted and approved by the relevant health authorities
Logistics and Supply: Coordinating the secure and timely delivery of pharmaceutical products.

Early Access Programs (EAPs) – Autorisation d'Accès Précoce (AAP)

The Autorisation d’Accès Précoce (AAP) provides early access to innovative medicines for patients with serious conditions and rare diseases.

Our Role in Early Access:

Regulatory Navigation: We ensure compliance with stringent EAP regulatory requirements.
Program Implementation: We assist in setting up and managing early access programs while liaising with health authorities.
Distribution: We ensure the efficient and compliant distribution of early access medications to healthcare providers.
Data Collection: Gathering real-world efficacy and safety data.

MARKET

MARKET ACCESS

A strategic approach and market analysis is essential to ensure successful pharmaceutical market entry. It needs to be put in place well in advance of the launch of the product (be it under EAP or for products with a marketing authorization). This includes competition monitoring, price negotiations, and health technology assessments (HTAs). Also, our seamless transition services ensure uninterrupted availability of treatments from early access to full marketing.